Australia TGA ARTG record

Cardiac electrophysiology application software

Australia TGA ARTG Registered Device · Ironbark Creek Investments · VectraCor Inc · Class IIb · Started March 02, 2018

Good Name: Ironbark Creek Investments - Cardiac electrophysiology application software

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: March 02, 2018
Effective Date: March 02, 2018

Sponsor

Name: Ironbark Creek Investments

Manufacturer

Name: VectraCor Inc
Country: United States of America
Address: 785 Totowa Road Suite 100, Totowa, NJ, 07512

Intended purpose

Computerised analysis of cardiac electrical data from ECG leads to detect acute myocardial ischaemic injury including AMI (acute myocardial infarction) for patients presenting with chest pain or presumed ACS (acute coronary syndrome).

About this record

Access comprehensive regulatory information for Cardiac electrophysiology application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Ironbark Creek Investments, manufactured by VectraCor Inc in United States of America. The device registration started on March 02, 2018.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.